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EC number: 237-623-4 | CAS number: 13870-28-5
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data

Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: No tables provided with report; results only discussed qualitatively. Therefore, limited amount of information available. For justification of read across see endpoint summary.
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Safety of the metal scavengers sodium metasilicate and sodium polyphosphate.
- Author:
- Saiwai, K. et al.
- Year:
- 1 980
- Bibliographic source:
- Internal Report Toho University
- Reference Type:
- secondary source
- Title:
- Unnamed
- Year:
- 2 004
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Application of Na-metasilicate via gavage from day 0 to 18 of gestation. Examination of fetuses and and newborns.
- GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- Disodium metasilicate
- EC Number:
- 229-912-9
- EC Name:
- Disodium metasilicate
- Cas Number:
- 6834-92-0
- IUPAC Name:
- disodium oxosilanediolate
- Details on test material:
- SOURCE: not reported
PURITY: not reported
IMPURITY/ADDITIVE/ETC.: not reported
ANY OTHER INFORMATION: the test substance was sodium metasilicate, 20% aqueous solution.
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- other: JLC-TCR
- Details on test animals or test system and environmental conditions:
- Well developed males and females 8-13 weeks of age and 27-35 g/animal.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Analytical verification of doses or concentrations:
- not specified
- Details on mating procedure:
- 1 male was caged with each female until a vaginal plug was observed, at which time the female was housed in a separate cage.
- Duration of treatment / exposure:
- 17-18 days
- Frequency of treatment:
- daily
- Duration of test:
- 18 days
Doses / concentrationsopen allclose all
- Dose / conc.:
- 12.5 mg/kg bw/day (nominal)
- Remarks:
- low dose
- Dose / conc.:
- 50 mg/kg bw/day (nominal)
- Remarks:
- medium dose
- Dose / conc.:
- 200 mg/kg bw/day (nominal)
- Remarks:
- high dose
- No. of animals per sex per dose:
- 33 and 27 animals respectively
- Control animals:
- yes
- Details on study design:
- 10 animals/cage were raised until mating. Mating was performed with 1 female and 1 male. Males were kept individually beginning 1 week before mating. After mating, animals were kept individually. The gestation period was determined by identifying the vaginal plug as day "zero" of pregnancy. The pregnant animals were randomly divided into 4 groups receiving volumes of 10 ml/kg bw of water (control), 12.5, 50 and 200 mg/kg bw sodium metasilicate by gavage. Treatment was repeated daily from day "zero" until day "seventeen". The living fetuses of 5 mothers, randomly chosen from each group, were fixed with Bouin's fixative for examinations of inner organs. The living fetuses of the other mothers were fixed using 95% ethanol followed by staining with Alizarin Red S for examination of skeleton anomalies.10 pregnant mice were allowed to deliver their young naturally. After parturition, neonates were arranged in groups of 8 randomly chosen neonates born by the same mother (if possible four male and four female/group) and nursed for 30 days. The weight of the main organs was determined in both mothers and neonates. Running Test: animals were placed on their backs on a plane inclined at 45° and their reaction classified into four patterns: animal fell down immediately; stayed motionless on the center; turned 90° and moved to the right or to the left; turned and moved to the top. Rod Grasping Test: the animals were gently held by their tails and lowered until their forefeet touched a fixed rod, when they were released. The time was measured from touching the rod until the animals fell from the rod. This test was conducted three times with each animal on the 6th, 8th, 10th and 14th day after birth.
Examinations
- Maternal examinations:
- - body weight
- Clinical observations: registered daily
ORGANS EXAMINED AT NECROPSY (MACROSCOPIC AND MICROSCOPIC):
- Organ weights P and F1: reported for F1 individuals only, 30 days after birth
- Histopathology P and F1: on day 30 after birth the offspring were necropsied and the skeletons stained and examined for - Ovaries and uterine content:
- counting of nidations, corpi lutei and living/dead fetuses
- Fetal examinations:
- STANDARDIZATION OF LITTERS:
after parturition the neonates were counted, and arranged into groups of 8 randomly chosen individuals born by the same mother (preferably 4 males and 4 females), for an unknown number of females from each group.
weighing of living fetuses and important organs, sex determination, examination of integument anomalies, naked eye examination of other changes
Parameters evaluated were: number of neonates, parturition failures, body weight gain, behavioral development in the Running and Rod Grasping Testand skeletal development. The running test on an inclined plane and the rod grasping test were conducted on day 6, 8, 10 and 14 after birth, to assess development.
ORGANS EXAMINED AT NECROPSY (MACROSCOPIC AND MICROSCOPIC):
- Organ weights P and F1: reported for F1 individuals only, 30 days after birth
- Histopathology P and F1: on day 30 after birth the offspring were necropsied and the skeletons stained and examined for
anomalies.
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:yes
Details on maternal toxic effects:
Parental data and F1:
- Body weight: no treatment-related effects were observed in either mother animals, fetuses delivered by hysterectomy or neonates.
- Fertility index: see table below
- Duration of gestation: 18 days
- Mortality: 2/27 females administered 50 mg/kg and 2/33 females administered 200 mg/kg died during the exposure period. In one female of the highest dose group all fetuses died at an early stage. No parturition fatalities were observed when mothers were allowed to deliver their young naturally.
- Gross pathology incidence and severity: observed skeletal malformations in neonates like cervical vertebrae, tail vertebrae and vomer adhesion occurred in the controls, too, and did not show a dosage correlation. No malformations of the skeleton or the inner organs of fetuses delivered by hysterectomy were observed; the frequency of malformations and abnormalities of the external integument, like opened eyes, cleft palate and exencephaly showed a slight tendency toward dose dependance, but it was lower than in the control. No effects on main organs of both mothers and neonates as compared to controls.
- Number of corpora lutea: No significant differences between control and test groups, but actual numbers not reported.
- Organ weight changes: No treatment-related effects of organ weights of mother animals and neonates; not reported for fetuses delivered by hysterectomy.
Effect levels (maternal animals)
- Dose descriptor:
- NOAEL
- Effect level:
- 12.5 mg/kg bw/day
- Based on:
- test mat.
- Basis for effect level:
- other: maternal toxicity
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects: no effects
Details on embryotoxic / teratogenic effects:
- Litter size and weights: There was a dose-related, but not statistically significant decrease in litter size.
- Post natal survival until weaning: no treatment-related effects on body weight gain.
- Effects on offspring: a dose-related, but not statistically significant decrease in embryo weight and delayed ossification process was observed.
- Postnatal growth, growth rate: no treatment related effects
- Other observations: no treatment-related effects in the Running Test and the Rod Grasping Test.
Effect levels (fetuses)
- Dose descriptor:
- NOAEL
- Effect level:
- > 200 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: no adverse effects oberserved at the high dose
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Any other information on results incl. tables
- Fertility index:
Dose [mg/kg bw/d] pregnancies/mated female % pregnancies
---------------------------------------------------------------
0 (control) 20/26 77%
12.5 22/24 92%
50 20/31 65%
200 21/25 84%
- Offspring toxicity F1:
Dose [mg/kg bw/d] average no. of neonates/litter
-----------------------------------------------------
0 (control) 14.7 +- 2.4
12.5 13.8 +- 2
50 12.9 +- 2
200 12.8 +- 2
Applicant's summary and conclusion
- Conclusions:
- No developmental effects were observed in this study up to and including 200 mg/kg bw/day. The NOAEL for developmental toxicity was determined to be > 200 mg/kg bw. The NOAEL for maternal toxicity was 12.5 mg/kg bw/day.
- Executive summary:
In a developmental toxicity study by Saiwai et al. (1980), pregnant mice were administered 12.5, 50 or 200 mg/kg bw/day sodium metasilicate in aqueous solution from day 0 until 17/18 of gestation by daily gavage. Among the mother animals 2 fatalities occurred both in the 50 and 200 mg/kg group (total number of animals: 33 and 27, respectively); body and organ weights and dissection findings were not affected. On day 18 of gestation fetuses were delivered by hysterectomy and examined. No differences to controls were observed for the following parameters: number of pregnancies and living or dead fetuses, body weight and malformations of inner organs and the skeleton. 10 mother animals were allowed to deliver their young naturally. The neonates were observed for 30 days. Litter size and fertility index were not significantly affected up to and including 200 mg/kg bw/day. Body weight gain, organ weights and behavioural development did not reveal any differences to the control. Skeletal malformations did not exhibit a correlation with dosage. The NOAEL for developmental toxicity was determined to be > 200 mg/kg bw/day. The NOAEL for maternal toxicity was 12.5 mg/kg bw/day.
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